Alvotech’s inflammation-targeting biosimilar AVT05 has been rejected by the U.S. Food and Drug Administration (FDA) because of issues with the company’s manufacturing facility in Reykjavik, Iceland.
The biosimilar-focused biotech was anticipating that AVT05 would be the first-to-market biosimilar of Johnson & Johnson’s Simponi (golimumab), a TNF-α inhibitor for chronic inflammatory diseases, in the US.
The total 2025 revenues for Alvotech are expected to drop to $570–$600m as a direct result of the FDA rejection, due to the cost of fixing facility issues and a resultant slowdown in production, according to the biotech. This is a drop from predictions made in the biotech’s Q1 2025 earnings report for $600–$700m in topline revenues.
J&J’s patent for Simponi expired in 2024 in the US and in 2025 in the EU. J&J has reported revenues totalling $2.06bn in the first three quarters of 2025. With the anticipated launch of biosimilars, annual global sales for Simponi are expected to fall, with annual estimates dropping to $743m in 2031, according to analyst consensus forecasts by GlobalData, the parent company of Pharmaceutical Technology.
A biologics license application (BLA) for AVT05 was filed with the FDA back in January 2025, per a company press release. A market authorisation application (MAA) for the biologic was also filed with the European Medicines Agency (EMA) in November 2024,. The EMA's Committee for Medicinal Products for Human Use (CHMP) provided a positive opinion of the biosimilar, recommending market authorisation approval. A decision from the European Commission is still pending.
Meanwhile in Japan, AVT05 has received marketing authorisation for treating rheumatoid arthritis (RA) in patients who have not sufficiently responded to conventional treatments. This saw AVT05 becoming the first Simponi biosimilar in a major global market, per a September 2025 press release.
Despite hurdles, Alvotech is gaining speed in the biosimilar space
The stumbling block in market authorisation for AVTO5 comes after a succession of regulatory approvals as Alvotech moves to assert dominance in the biosimilar landscape.
Alvotech and Teva Pharma’s injectable Selarsdi became available as an interchangeable biosimilar to reference J&J’s biologic Stelara (ustekinumab) on 30 April 2025 for various inflammatory conditions like psoriatic arthritis, plaque psoriasis, ulcerative colitis and Crohn’s disease.
Alvotech, with its strategic commercialisation partner Advanz Pharma, received EMA approval for Mynzepli (AVT06) in August 2025. Mynzepli is a biosimilar to vascular endothelial growth factors (VEGF) inhibitor Eylea (aflibercept) sold by Regeneron Pharmaceuticals and Bayer for the treatment of various eye conditions.
In addition to AVT05, Alvotech along with commercialisation partner Fuji Pharma, received marketing for two other biosimilars, AVT03, a biosimilar to Ranmark (denosumab) and AVT06, per a September 2025 press release. AVT06 and AVT03 are still under consideration for approval by the FDA and EMA.
